Development of new products

Project leaders: Sandra Hazelaar PhD and Margriet Dijkstra-Tiekstra PhD

Cryoseal®

From 2008 cryoseal, a fibrin glue of single donor plasma which Sanquin has started to produce as an alternative for autologous or pooled plasma fibrin glues, is produced in a routine setting. The storage life of cryoseal is one year and is based on stability research performed by ThermoGenesis. In 2009 TraM has started a formal stability study to officially confirm the one year storage life of cryoseal. The second goal of this study is to collect data to extend the storage life to two years. Data of storage of cryoseal for up to 12 months is already available. Another part of this study is testing of the integrity of the overwrap of the syringes containing cryoseal which will be performed at the end of the stability study (2011).

Other studies in correlation to cryoseal are:

• The packaging of cryoseal: this is very important to minimize damage to the overwrap and syringes during storage and transport. A cardboard box has been developed for the cryoseal syringes in which they are firmly packed and the barcodes well scanable. The validation of these boxes has been completed and the boxes are now used as standard packaging material.
• Transport of cryoseal: to guarantee the quality of the product it is absolutely mandatory that the temperature remains below -18°C during all the different steps of packaging and transportation. A start was made with the mapping of the freezing and thawing curve of the different cryoseal volumes. Also, a simulation was made of the cryoseal route after production to monitor the temperature of the product during transportation.
• Homogeneity: The homogeneity of the 4 syringes of one batch was determined. No difference was found between the 4 syringes indicating that the cryoprecipitate and thrombin is mixed well before it is divided over the syringes.

A new proposal for a randomized multi-center study for the use of cryoseal in knee replacement was initiated and approved. This proposal is a collaboration between the Sanquin Blood Bank in Leiden and Groningen, with JA van Hilten as project leader (SW). Preparations were made for the start of the study in 2011.

Non-invasive pH measurement in PCs

TraM has performed a large field evaluation involving five blood bank departments and four participating hospitals. Blood Cell Storage, Inc. (BCSI) has developed a detection system to measure the pH in platelet concentrates (PCs) in a non-invasive way.During 15 months (June 2009-September 2010) all PCs were prepared in this especially designed storage bag. This storage bag enables pH measurement at any time during storage without sampling. In the study the BCSI pH1000 meter is evaluated for routine use. Also the pH of the PCs were studied to determine whether or not there is a correlation with the in vitro quality and/or bacterial contamination, storage time and the platelet increment after transfusion. TraM coordinated production, logistics, execution of the experiments, data collection, and overall analysis. It appeared that the BCSI pH1000 is easy to use in routine settings. A correlation has been found between storage day of the PCs and pH, but not between pH and bacterial contamination. Also no correlation was found between pH at day of transfusion and the platelet increment after transfusion.For this latter is has to be mentioned that almost all transfused PCs appeared to have a pH between 6.9 and 7.4, while an effect can be expected for the lower pH ranges (6.4-6.8).  

Mean pH profile of PCs (n=13963) during storage as measured using the BCSI pH1000	BCSI pH 1000